The Effect of Vitamin D on in Vitro Fertilization Outcome

Completed

• Conditions: Ongoing Pregnancy Rate; Vitamin D; In Vitro Fertilization
• Interventions: Procedure: Embryo transfer

• Registration Number: NCT02361827
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief Summary

To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Thus, here the investigators carry this prospective observational cohort study to demonstrate the relationship between vitamin D level and IVF outcome.

Detailed Description

Vitamin D level is measured before the commence of IVF cycle. According to Vitamin D level, patients are divided into 3 groups: A, Deficient, \<20 ng/mL; B, Insufficient, 20-29.9 ng/mL; C, Replete, \>30 ng/mL.

Ongoing pregnancy rate are compared among these three groups after controlling age, number of embryos transferred, ect.

In addition, Vitamin D level is also meassured before embryo transfer in FET cycles with PGT treatment. The effect of Vitamin D on IVF outcome is detected in patients transferred with Euploid embryos.

Study Timeline

• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-12
• Study Start: 2018-01-01
• Primary Completion: 2022-09-01
• Study Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 688

Inclusion Criteria

1. age between 21-40 years old
2. basal FSH hormone level less than 10 mIU/mL
3. the first cycle of IVF treatment with standard long protocol
4. both ovarian present and normal uterus.

Exclusion Criteria

1. Important data missing
2. Gametes donation cycles
3. Anyone that does not meet the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A1, Vitamin D deficient	Embryo transfer	Vitamin D level before cycle \< 20 ng/mL.
C2, Vitamin D replete	Embryo transfer	Vitamin D level before ET \> 30 ng/mL (FET with Euploid embryos)
B1, Vitamin D insufficient	Embryo transfer	Vitamin D level before cycle 20-29.9 ng/mL
C1, Vitamin D replete	Embryo transfer	Vitamin D level before cycle \> 30 ng/mL
B2, Vitamin D insufficient	Embryo transfer	Vitamin D level before ET 20-29.9 ng/mL (FET with Euploid embryos)
A2, Vitamin D deficient	Embryo transfer	Vitamin D level before ET \< 20 ng/mL (FET with Euploid embryos)

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	12 weeks after embryo transfer	12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

Secondary Outcome Measures

Name	Time	Method
Ectopic pregnancy rate	35 days after embryo transfer	Ectopic pregnancy is defined as serum HCG positive, yet with no gestational sac present inside uterine cavity

Trial Locations

Locations (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China